15
Nov
2023

FDA Recall: Software Crash when Simultaneous Use of Device Functions

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Company: Philips North America
Date of Enforcement Report: 11/15/2023
Class II

PRODUCT

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Recall Number:

Z-0306-2024

REASON:

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

RECALLING FIRM/MANUFACTURER:

Philips North America

VOLUME OF PRODUCT IN COMMERCE:

1 unit

DISTRIBUTION:

US Nationwide distribution in the state of MN.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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